British-Swedish biopharmaceutical company AstraZeneca PLC (STO/LON/Nasdaq: AZN), said on Monday that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Saphnelo (anifrolumab) as a once-weekly, self-administered subcutaneous pre-filled pen for adults with systemic lupus erythematosus on top of standard therapy.

The recommendation was based on interim results from the Phase III TULIP-SC trial showing a statistically significant and clinically meaningful reduction in disease activity versus placebo in participants with moderate to severe, active, autoantibody-positive disease while receiving standard therapy.

The safety profile for subcutaneous administration was reported as consistent with the known profile for Saphnelo administered intravenously.

TULIP-SC randomised 367 participants 1:1 to receive a 120 mg subcutaneous dose of anifrolumab or placebo and implemented a planned interim analysis when the first 220 participants reached week 52. The trial includes a 52-week open-label extension for participants who have completed the initial 52 week treatment.

Saphnelo intravenous infusion is approved for moderate to severe systemic lupus erythematosus in more than 70 countries including the United States, the European Union and Japan, and more than 40,000 patients have been treated globally.